TREATMENT OF AORTO-ILIAC AND INFRA-INGUINAL VASCULAR INFECTIONS WITH A PREFABRICATED BOVINE PERICARDIAL GRAFT.

OBJECTIVE: The use of biological grafts provides acceptable mid- and long-term results in native or prosthetic vascular infections. Several reports describe the successful use of bovine pericardium in case of vascular infections, mainly as a large patch to be sutured as a tubular graft. Recently, a novel prefabricated bovine pericardium graft (Biointegral Surgical No-React® Inc, Mississauga, ON, Canada) has been introduced in clinical practice with promising results. In this study, we report our preliminary experience utilizing Biointegral Surgical graft in case of native and or prosthetic aorto-iliac and infra-inguinal infection. METHODS: We retrospectively analyzed data from 20 patients with native or prosthetic aorto-iliac and infra-inguinal infection who underwent in situ reconstruction with a Biointegral Surgical No-React bovine pericardium prosthesis between October 2020 and February 2023 at the Vascular Surgery Unit of the Fondazione Policlinico Universitario Gemelli - IRCCS in Rome, Italy. All patients followed a standardized protocol including postoperative anticoagulation and long-term intravenous antibiotics. RESULTS: The indication for surgery was: mycotic aortic aneurysm in four patients (20%), graft infection after abdominal aortic repair in 11 patients (55%), peripheral graft infection in five patients (25%). Complete excision of the infected aorta or prosthetic graft, surgical debridement and in situ reconstruction were performed in all patients. Hospital mortality rate was 5% (n=1) and graft-related mortality of 0%. During follow-up (median 13 months, range 6-34 months), reinfection was 5.2% and primary graft patency 94.7%. CONCLUSIONS: The use of prefabricated bovine pericardial grafts represent a promising option for the treatment of native and prosthetic aorto-iliac and infra-inguinal infections. The application of this biological graft with a standardized post-operative protocol has been associated with a satisfactory patency and reinfection rate without increased bleeding complications.

Mechanical versus Bioprosthetic Aortic Valve Replacement in Patients Aged 50 to 70 Years.

Background: This study compared the outcomes of surgical aortic valve replacement (AVR) in patients aged 50 to 70 years based on the type of prosthetic valve used. Methods: We compared patients who underwent mechanical AVR to those who underwent bioprosthetic AVR at our institution between January 2000 and March 2019. Competing risk analysis and the inverse probability of treatment weighting (IPTW) method based on propensity score were employed for comparisons. Results: A total of 1,580 patients (984 patients with mechanical AVR; 596 patients with bioprosthetic AVR) were enrolled. There was no significant difference in early mortality between the mechanical AVR and bioprosthetic AVR groups (0.9% vs. 1.7%, p=0.177). After IPTW adjustment, the risk of all-cause mortality was significantly higher in the bioprosthetic AVR group than in the mechanical AVR group (hazard ratio [HR], 1.39; 95% confidence interval [CI], 1.07-1.80; p=0.014). Competing risk analysis revealed lower risks of stroke (sub-distributional hazard ratio [sHR], 0.44; 95% CI, 0.28-0.67; p<0.001) and anticoagulation-related bleeding (sHR, 0.35; 95% CI, 0.23-0.53; p<0.001) in the bioprosthetic AVR group. Conversely, the risk of aortic valve (AV) reintervention was higher in the bioprosthetic AVR group (sHR, 6.14; 95% CI, 3.17-11.93; p<0.001). Conclusion: Among patients aged 50 to 70 years who underwent surgical AVR, those receiving mechanical valves showed better survival than those with bioprosthetic valves. The mechanical AVR group exhibited a higher risk of stroke and anticoagulation-related bleeding, while the bioprosthetic AVR group showed a higher risk of AV reintervention.

Platelet Reduction after Transcatheter Aortic Valve Implantation: Results from the PORTRAIT Study.

Background: An unexplained condition that follows transcatheter aortic valve implantation (TAVI) is platelet count reduction (PR). According to published research, patients with balloon-expandable valves (BEVs) had a greater PR than those with self-expandable valves (SEVs). Objectives: The purpose of this study was to investigate the incidence and clinical effects of PR following TAVI. Methods: In total, 1.122 adult TAVI patients were enrolled. Propensity score matching was carried out in a 1:1 ratio between patients with BEVs and those with SEVs. The analysis included changes in platelet count, in-hospital mortality, and early postoperative adverse events. Results: Notably, 632 patients were matched (BEV:316; SEV:316). All patients' post-procedural platelet counts changed according to a parabolic curve, using a mixed regression model for repeated analyses (estimate = -0.931; standard error = 0.421; p = 0.027). The platelet count varied comparably in patients with BEVs and SEVs (estimate = -4.276, standard error = 4.760, p = 0.369). The average time for obtaining the nadir platelet count value was three days after implantation (BEV: 146 (108-181) vs. SEV: 149 (120-186); p = 0.142). Overall, 14.6% of patients (92/632) had post-procedural platelet count <100,000/µL. There was no difference between the two prosthesis types (BEV:51/316; SEV:41/316; p = 0.266). Thrombocytopenia was found to be significantly linked to blood product transfusions, lengthier stays in the intensive care unit and hospital, and in-hospital mortality. Conclusions: TAVI, irrespective of the type of implanted valve, is linked to a significant but temporary PR. Thrombocytopenia increases the risk of serious complications and in-hospital death in TAVI patients. To explore and clarify the causes and associated effects, further prospective research is necessary.

Enhancing Transcatheter Aortic Valve Implantation (TAVI) outcomes through virtual proctoring: a case series analysis.

Transcatheter Aortic Valve Implantation (TAVI) represents a pivotal advancement in the management of severe aortic stenosis, offering a minimally invasive alternative to surgical valve replacement. Despite its widespread adoption, the complexity of TAVI procedures, especially in high-risk anatomical scenarios such as valve-in-valve interventions, necessitates ongoing educational support for operators. This article explores the implementation of a virtual proctoring system for complex TAVI procedures, evaluating its feasibility, educational value, and impact on procedural success and safety.

Transcatheter valve-in-valve implantation treatment with the J-valve system for tricuspid bioprosthesis deterioration: a report of two cases.

Background: Patients with tricuspid bioprosthetic structural valve degeneration (SVD) often present with right ventricular enlargement and severe dysfunction, which cause a higher risk for redo cardiac surgery. In 2019, our center innovated using the J-valve system for valve-in-valve (ViV) implantation to treat tricuspid bioprosthetic SVD. The purpose of this study was to summarize the clinical effect after 1-year follow-up. Case Description: From April 2019 to October 2019, two cases of tricuspid bioprosthetic dysfunction were treated with the J-valve system. Both patients were male, aged 46 and 67 years, respectively. The preoperative evaluation showed that the risk of conventional redo open heart surgery was high. The J-valve implantation was successful in both cases. One patient had slight valve displacement when the transporter was withdrawn during the operation, and a second J-valve was implanted in an ideal position. There was no death, no delayed valve displacement, and no readmission during the follow-up period of 12 months. In both cases, there was an absence of trace tricuspid regurgitation. After 6 months of anticoagulation with warfarin, the patients were converted to long-term aspirin treatment. Conclusions: The ViV technique with J-valve is feasible and effective in treating tricuspid bioprosthetic SVD in high-risk patients, avoiding cardiopulmonary bypass and conventional thoracotomy injury.

Reparação da parede abdominal com membranas acelulares de pericárdio bovino - Parte I - Achados clínicos e radiológicos / Abdominal wall repair with acellular bovine pericardial membranes - Part I - Clinical and radiological findings

Introdução: Reduzindo os índices de recidiva de forma impactante, o emprego de biomateriais como "telas de reforço" na reparação de diferentes defeitos da parede abdominal tornou-se rotina quase obrigatória para o sucesso dessas reparações. A partir da década de 1990 houve a introdução de matrizes biológicas acelulares, iniciando-se assim uma nova era na reparação dos defeitos da parede abdominal. O objetivo é avaliar a funcionalidade do pericárdio bovino acelularizado em reparações da parede abdominal. Método: Trinta pacientes foram submetidos a reparação de defeitos da parede abdominal, com biopróteses acelulares de pericárdio bovino, perfazendo um total de 40 implantes anatomicamente individualizados. O seguimento médio foi de 31 meses, sendo os pacientes avaliados clinicamente e radiologicamente. Em três casos foram feitas biópsias das áreas implantadas permitindo análise histológica do material. Resultados: Não se observou recidiva das herniações em nenhum dos casos, tanto clinica como radiologicamente. Também não houve registro de hematomas, infecções ou qualquer fenômeno de natureza reacional local ou sistêmica. Radiologicamente, não foi possível visualizar as matrizes no local de implantação em qualquer dos períodos de pós-operatório analisados. Conclusão: As matrizes mostraram similaridade às demais membranas biológicas descritas na literatura internacional. Representando uma importante atualização e evolução conceitual, as membranas acelulares de pericárdio bovino podem ser incorporadas ao arsenal terapêutico nas reparações de parede abdominal.

Introduction: Reducing recurrence rates significantly, the use of biomaterials as "reinforcement meshes" in the repair of different abdominal wall defects has become an almost mandatory routine for the success of these repairs. From the 1990s onwards, acellular biological matrices were introduced, thus beginning a new era in the repair of abdominal wall defects. The objective is to evaluate the functionality of the acellularized bovine pericardium in abdominal wall repairs. Method: Thirty patients underwent repair of abdominal wall defects using acellular bovine pericardium bioprostheses, making a total of 40 anatomically individualized implants. The average follow-up was 31 months, with patients being evaluated clinically and radiologically. In three cases, biopsies were taken from the implanted areas, allowing histological analysis of the material. Results: No recurrence of herniations was observed in any of the cases, both clinically and radiologically. There were also no records of bruises, infections or any phenomenon of a local or systemic reaction nature. Radiologically, it was not possible to visualize the matrices at the implantation site in any of the postoperative periods analyzed. Conclusion: The matrices showed similarity to other biological membranes described in the international literature. Representing an important update and conceptual evolution, acellular bovine pericardial membranes can be incorporated into the therapeutic arsenal in abdominal wall repairs.

Reparação da parede abdominal com membranas acelulares de pericárdio bovino - Parte II - Análises histológicas e morfométricas / Repair of the abdominal wall with acellular bovine pericardial membranes - Part II - Histological and morphometric analyses

Introdução: Análise histológica é a principal ferramenta de avaliação de biopróteses acelulares, em sua maioria em caráter experimental. O objetivo é analisar histologicamente a matriz acelular de pericárdio bovino em reparações de parede abdominal implantada em humanos. Método: De uma série de 30 reparações com a membrana, 3 pacientes foram submetidas a revisão cirúrgica não relacionada aos implantes, aos 13, 22 e 23 meses de pós-operatório, obtendo-se biópsias das áreas previamente implantadas. Além da avaliação dos aspectos básicos de biocompatibilidade e neoformação tecidual, as lâminas foram digitalizadas e submetidas a análise computadorizada com o software ImageJ para quantificação da cinética de degradação das membranas, associada à análise da dimensão fractal das amostras. Os valores obtidos para porcentagens de membrana residual tiveram suas médias comparadas por análise de variância (ANOVA) e pelo teste T de Student não pareado, também utilizado para os valores da quantificação da dimensão fractal. Resultados: Foi demonstrada a biocompatibilidade do material, com neoformação tecidual, deposição de colágeno e tecido celularizado de aspecto normal, sem reações locais importantes. Fragmentos residuais da membrana foram quantificados em 40%±7% aos 13 meses, em 20%±6% aos 22 meses e em 17%±6% aos 23 meses de pós-operatório, com a análise da dimensão fractal indicando uma progressiva degradação dos implantes, com significância estatística entre 13 meses e as amostras tardias. Conclusão: Os resultados atestaram a funcionalidade do pericárdio bovino acelular sob diferentes níveis de estresse mecânico nas reparações da parede abdominal em humanos.

Introduction: Histological analysis is the main tool for evaluating acellular bioprostheses, mostly on an experimental basis. The objective is to histologically analyze the acellular matrix of bovine pericardium in abdominal wall repairs implanted in humans. Method: From a series of 30 repairs with the membrane, 3 patients underwent surgical revision unrelated to the implants at 13, 22, and 23 months postoperatively, obtaining biopsies of the previously implanted areas. In addition to evaluating the basic aspects of biocompatibility and tissue neoformation, the slides were digitalized and subjected to computerized analysis with the ImageJ software to quantify the kinetics of membrane degradation associated with the analysis of the fractal dimension of the samples. The values obtained for percentages of residual membrane had their means compared by analysis of variance (ANOVA) and the unpaired Student's T test, also used for the fractal dimension quantification values. Results: The biocompatibility of the material was demonstrated, with tissue neoformation, collagen deposition, and cellularized tissue with a normal appearance without important local reactions. Residual fragments of the membrane were quantified at 40%±7% at 13 months, at 20%±6% at 22 months, and at 17%±6% at 23 months postoperatively, with the analysis of the fractal dimension indicating a progressive degradation of implants, with statistical significance between 13 months and late samples. Conclusion: The results confirmed the functionality of the acellular bovine pericardium under different levels of mechanical stress in abdominal wall repairs in humans.

Aortic valve neocuspidization and bioprosthetic valves: Evaluating turbulence haemodynamics.

Aortic valve disease is often treated with bioprosthetic valves. An alternative treatment is aortic valve neocuspidization which is a relatively new reparative procedure whereby the three aortic cusps are replaced with patient pericardium or bovine tissues. Recent research indicates that aortic blood flow is disturbed, and turbulence effects have yet to be evaluated in either bioprosthetic or aortic valve neocuspidization valve types in patient-specific settings. The aim of this study is to better understand turbulence production in the aorta and evaluate its effects on laminar and turbulent wall shear stress. Four patients with aortic valve disease were treated with either bioprosthetic valves (n=2) or aortic valve neocuspidization valvular repair (n=2). Aortic geometries were segmented from magnetic resonance images (MRI), and 4D flow MRI was used to derive physiological inlet and outlet boundary conditions. Pulsatile large-eddy simulations were performed to capture the full range of laminar, transitional and turbulence characteristics in the aorta. Turbulence was produced in all aortas with highest levels occurring during systolic deceleration. In the ascending aorta, turbulence production is attributed to a combination of valvular skew, valvular eccentricity, and ascending aortic dilation. In the proximal descending thoracic aorta, turbulence production is dependent on the type of arch-descending aorta connection (e.g., a narrowing or sharp bend) which induces flow separation. Laminar and turbulent wall shear stresses are of similar magnitude throughout late systolic deceleration and diastole, although turbulent wall shear stress magnitudes exceed laminar wall shear stresses between 27.3% and 61.1% of the cardiac cycle. This emphasises the significance of including turbulent wall shear stress to improve our comprehension of progressive arterial wall diseases. The findings of this study recommend that aortic valve treatments should prioritise minimising valvular eccentricity and skew in order to mitigate turbulence generation.

Thrombocytopenia among Patients Undergoing Aortic Valve Replacement Using the Sutureless Perceval S Bioprosthesis: A Retrospective Study.

BACKGROUND: The sutureless Perceval S bioprosthesis is associated with postoperative thrombocytopenia. Our objectives were to compare the incidence, severity, and clinical implications of thrombocytopenia after aortic valve replacement (AVR) using the Perceval S or the Trifecta bioprosthesis. METHODS: Patients who underwent AVR between March 2016 and August 2019 using the Perceval or Trifecta were retrospectively included. The primary endpoint was the nadir in platelet counts within 15 days after surgery. Secondary endpoints included postoperative hemolysis and inflammatory parameters, as well as clinical and echocardiographic outcomes. RESULTS: Overall, 156 patients were included (Perceval, n = 103; Trifecta, n = 53). Preoperatively, there was no difference in platelet counts between the two groups. Postoperatively, the Perceval S bioprosthesis was associated with a greater decrease in platelet counts. The nadir was reached at Day 3 for both groups, but thrombocytopenia was more severe for the Perceval S (Perceval S vs. Trifecta, 89.2 ± 37.7 × 109/L vs. 106.5 ± 34.1 × 109/L, p = 0.01). No difference regarding lactate dehydrogenase, C-reactive protein, and white blood cells count was found. All-cause 30-day mortality rates (both valves, 2%, p = 0.98), hospital lengths of stay, and re-operation rates were similar. CONCLUSION: The Perceval S bioprosthesis was associated with more severe postoperative thrombocytopenia. This did not translate into higher short-term morbidity or mortality.

Early and mid-term outcomes after aortic valve replacement using a novel tissue bioprosthesis: a systematic review.

OBJECTIVES: While current data show a clear trend towards the use of bioprosthetic valves during aortic valve replacement (AVR), durability of bioprosthetic valves remains the most important concern. We conducted a 1st systematic review of all available evidence that analysed early and mid-term outcomes after AVR using the Inspiris RESILIA™ bioprosthesis. METHODS: A systematic literature search was performed to identify all relevant studies evaluating early and mid-term outcomes after AVR using the Inspiris RESILIA bioprosthesis and including at least 20 patients with no restriction on the publication date. Subgroup meta-analysis was performed to compare Inspiris RESILIA and PERIMOUNT Magna Ease bioprosthesis and to pool the early postoperative mortality and stroke rates. RESULTS: A total of 416 studies were identified, of which 15 studies met the eligibility criteria. The studies included a total of 3202 patients with an average follow-up of up to 5.3 years. The average age of patients across the studies was 52.2-75.1 years. Isolated AVR was performed in 39.0-86.4% of patients. In-hospital or 30-day postoperative mortality was 0-2.8%. At the mid-term follow-up, freedom from all-cause mortality was up to 85.4%. Among studies with mid-term follow-up, trace/mild paravalvular leak was detected in 0-3.0%, while major paravalvular leak was found only in up to 2.0% of patients. No statistically significant differences in terms of mortality (P = 0.98, odds ratio 1.02, 95% confidence interval 0.36-2.83) and stroke (P = 0.98, odds ratio 1.01, 95% confidence interval 0.38-2.73) between the Inspiris RESILIA bioprosthesis and PERIMOUNT Magna Ease bioprosthesis were observed in the subgroup meta-analysis. CONCLUSIONS: Mid-term data on the safety and haemodynamic performance of the novel aortic bioprosthesis are encouraging. Further comparative studies with other bioprostheses and longer follow-up are still required to endorse durability and safety of the novel bioprosthesis.

Clinical Outcomes Following Transcatheter Mitral Valve-in-Valve Replacement Using a Meril Myval Transcatheter Heart Valve.

AIM: Transcatheter mitral valve-in-valve (TMViV) replacement for degenerated surgically implanted bioprosthetic valves has been described by both transseptal and transapical approaches. The balloon-expandable Myval transcatheter valve (Meril Life Sciences, Vapi, India) is commonly used for transcatheter valve-in-valve procedures in India. This study aimed to report in-hospital, 30-day, and 1-year outcomes of Myval patients who underwent TMViV in a single tertiary care centre in India. METHODS: Symptomatic patients with surgical bioprosthetic mitral valve failure with New York Heart Association (NYHA) class III-IV symptoms, despite optimal medical therapy and high or very high risk for redo surgery, were assigned to TMViV following heart team discussions. Data were retrospectively collected and outcomes assessed. RESULTS: Twenty patients were treated, with mean age 64.4 years, 60% were female, and mean Society of Thoracic Surgeons (STS) predicted risk of operative mortality score was 8.1. The failure mechanism was combined stenosis and regurgitation in 60% of patients. Technical success was achieved in 100% of patients. The mean postprocedure and 30-day gradients were 4.6±2.7 and 6.3±2.1, respectively. None of them had significant valvular or paravalvular leaks or left ventricular outflow tract obstruction. All-cause mortality at 1 year was 10%, and all survivors were in New York Heart Association (NYHA) class I or II. CONCLUSION: TMViV replacement with a Meril Myval can be safely performed with high technical success, and low 30-day and 1-year mortality.

A challenging transseptal mitral valve in valve case report: Success and safety.

Key Clinical Message: Transcatheter mitral valve implantation (TMVI) is considered a less-invasive approach than open-heart surgery, favored in high-risk patients elected for valve replacement. Although seemingly suitable, this procedure is highly operator-dependent. Abstract: Transcatheter mitral valve implantation (TMVI) is an alternative in high-risk patients. We reported a 72-year-old patient with mitral bioprosthesis degeneration successfully receiving TMVI. The procedure has lower morbidity and mortality rate than the surgical approach but can be accompanied by several complications, especially when conducted by an inexperienced operator.

Revolutionizing cardiovascular care: the power of histotripsy.

Histotripsy, an innovative ultrasonic technique, is poised to transform the landscape of cardiovascular disease management. This review explores the multifaceted applications of histotripsy across various domains of cardiovascular medicine. In thrombolysis, histotripsy presents a non-invasive, drug-free, and precise method for recanalizing blood vessels obstructed by clots, minimizing the risk of vessel damage and embolism. Additionally, histotripsy showcases its potential in congenital heart defect management, offering a promising alternative to invasive procedures by creating intracardiac communications noninvasively. For patients with calcified aortic stenosis, histotripsy demonstrates its effectiveness in softening calcified bioprosthetic valves, potentially revolutionizing valve interventions. In the realm of arrhythmias, histotripsy could play an important role in scar-based ventricular tachycardia ablation, eliminating channel-like isthmuses of slowly conducting myocardium. Histotripsy`s potential applications also extend to structural heart interventions, enabling the safe sectioning of basal chordae and potentially addressing mitral regurgitation. Furthermore, it showcases its versatility by safely generating ventricular septal defects, providing a non-invasive means of creating intracardiac communications in neonates with congenital heart disease. Yet, most supporting studies are in-vitro or animal studies and there are possible challenges in translating experimental data on cardiac histotripsy to the clinical level. As histotripsy continues to evolve and mature, its remarkable potential in cardiovascular disease management holds promise for improving patient outcomes and reducing the burden of invasive procedures in the field of cardiology.

Early Outcomes of Pulmonary Valve Replacement With the Edwards Inspiris Resilia Pericardial Bioprosthesis.

BACKGROUND: Controversy regarding the optimal pulmonary valve substitute remains, with no approved surgical valve for pulmonary valve replacement (PVR). Furthermore, unfavorable anatomy often precludes transcatheter PVR in patients with congenital heart disease. We therefore sought to evaluate the feasibility of the Edwards Inspiris pericardial aortic bioprosthesis in the pulmonary position in pediatric and adult patients requiring PVR. METHODS: Data from consecutive patients who underwent PVR from February 2019 to February 2021 at our institution were retrospectively reviewed. Postoperative adverse events included paravalvular or transvalvular leak, endocarditis, explant, thromboembolism, valve thrombosis, valve-related bleeding, hemolysis, and structural valve degeneration. Progression of valve gradients was assessed from discharge to 30 days and one year. RESULTS: Of 24 patients with median age of 26 years (interquartile range [IQR]: 17-33; range: 4-60 years), 22 (91.7%) patients had previously undergone tetralogy of Fallot repair and 2 (8.3%) patients had undergone double-outlet right ventricle repair in the neonatal period or infancy. All patients had at least mild right ventricular (RV) dilatation (median RV end-diastolic volume index 161.4, IQR: 152.3-183.5 mL/m2) and at least moderate pulmonary insufficiency (95.8%) or stenosis (8.3%). Median cardiopulmonary bypass and cross-clamp times were 71 (IQR: 63-101) min and 66 (IQR: 60-114) min, respectively. At a median postoperative follow-up of 2.5 years (IQR: 1.4-2.6; range: 1.0-3.0 years), there were no mortalities, valve-related reoperations, or adverse events. Postoperative valve gradients and the severity of pulmonary regurgitation did not change significantly over time. CONCLUSIONS: At short-term follow-up, the bioprosthesis in this study demonstrated excellent safety and effectiveness for PVR. Further studies with longer follow-up are warranted.

Revisiting aortic valve prosthesis choice in patients younger than 50 years: 10 years results of the AUTHEARTVISIT study.

OBJECTIVES: This population-based cohort study investigated mid-term outcome after surgical aortic valve replacement with a bioprosthetic or mechanical valve prosthesis in patients aged <50 years in a European social welfare state. METHODS: We analysed patient data from the main social insurance carriers in Austria (2010-2020). Subsequent patient-level record linkage with national health data provided patient characteristics and clinical outcome. Survival, reoperation, myocardial infarction, heart failure, embolic stroke or intracerebral haemorrhage, bleeding other than intracerebral haemorrhage and major adverse cardiac events were evaluated as outcomes. RESULTS: A total of 991 patients were analysed. Regarding demographics, no major differences between groups were observed. Multivariable Cox regression revealed no significant difference in overall survival (P = 0.352) with a median follow-up time of 6.2 years. Reoperation-free survival was decreased (hazard ratio = 1.560 [95% CI: 1.076-2.262], P = 0.019) and the risk for reoperation was increased (hazard ratio = 2.770 [95% CI: 1.402-5.472], P = 0.003) in patients who received bioprostheses. Estimated probability of death after reoperation was 0.23 (CL: 0.08-0.35) after 2 years and 0.34 (CL: 0.06-0.53) after 10 years over both groups. Regarding further outcomes, no significant differences between the two groups were observed. CONCLUSIONS: In patients below 50 years of age receiving aortic valve replacement, implantation of bioprostheses when compared to mechanical heart valve prostheses was associated with a significantly higher rate of reoperations and reduced reoperation-free survival. Nevertheless, we could not observe a difference in overall survival. However, long-term follow-up has to evaluate that a significantly lower rate of reoperations may translate in consistently improved long-term survival.

Endothelial Microparticles: Markers of Inflammatory Response After Sutureless Valve Implantation

ABSTRACT Introduction: Systemic inflammatory response syndrome (SIRS) is related to increased circulating endothelial microparticles (EMP). Objective: The aim of this study was to compare the plasma concentration of EMP between patients undergoing aortic valve replacement with conventional bioprosthesis implantation and Perceval™ S (LivaNova) and to evaluate its impact on the inflammatory response in the short-term follow-up. Methods: This is a randomized clinical trial with 24 patients submitted to isolated aortic valve replacement divided into two groups: Perceval™ S (Group P) and conventional bioprostheses (Group C). Incidence of severe SIRS (three or more criteria) in the first 48 hours postoperatively, EMP release profile, interleukins (IL) 6 and 8, C-reactive protein, and procalcitonin were analyzed preand postoperatively at 24 hours and three months. Results: There were 24 patients (12 in each group), mean age was 69.92±5.17 years, 83.33% were female, the incidence of severe SIRS was 66.7% and 50% in groups C and P, respectively (P=0.68), and EMP showed a significant increase in the 24-hour postoperative period (P≤0.001) and subsequent decrease in the three-month postoperative period (P≤0.001), returning to baseline levels. For IL-6 and IL-8, there was a greater increase in group C at 24 hours postoperatively (P=.0.02 and P<0.001). Conclusion: The incidence of severe SIRS was similar in both groups, with significantly higher levels of IL-6 and IL-8, at the 24-hour postoperative period, in group C, however with higher levels of EMP in group P, and subsequent return to baseline levels at the three-month postoperative period in both groups.

Prognostic Impact of Residual Moderate Mitral Regurgitation Following Valve-in-Valve Transcatheter Aortic Valve Implantation

ABSTRACT Introduction: The impact of mitral regurgitation (MR) on valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) in patients with failed bioprostheses remains unclear. The purpose of this study was to assess the prognostic impact of residual moderate MR following VIV-TAVI. Methods: We retrospectively analyzed 127 patients who underwent VIV-TAVI between March 2010 and November 2021. At least moderate MR was observed in 51.2% of patients before the procedure, and MR improved in 42.1% of all patients. Patients with postoperative severe MR, previous mitral valve intervention, and patients who died before postoperative echocardiography were excluded from further analyses. The remaining 114 subjects were divided into two groups according to the degree of postprocedural MR: none-mild MR (73.7%) or moderate MR (26.3%). Propensity score matching yielded 23 pairs for final comparison. Results: No significant differences were found between groups before and after matching in early results. In the matched cohort, survival probabilities at one, three, and five years were 95.7% vs. 87.0%, 85.0% vs. 64.5%, and 85.0% vs. 29.0% in the none-mild MR group vs. moderate MR-group, respectively (log-rank P=0.035). Among survivors, patients with moderate MR had worse functional status according to New York Heart Association (NYHA) class at follow-up (P=0.006). Conclusion: MR is common in patients with failed aortic bioprostheses, and improvement in MR-status was observed in over 40% of patients following VIV-TAVI. Residual moderate MR after VIV-TAVI is not associated with worse early outcomes, however, it was associated with increased mortality at five years of follow-up and worse NYHA class among survivors.

Systematic review of first-in-human and early phase clinical trials for surgically implantable biological mitral valve substitutes.

BACKGROUND: The aim of this review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of biological mitral valve replacement. The need for consistent methodology in these early trials was highlighted by the observation of significant variability in the methods and protocols used across different research. METHODS: An extensive search through six major databases was carried out to retrieve First-In-Human (FIH) clinical studies evaluating surgically implanted bio-prostheses in the mitral position. RESULTS: Following the PRISMA guideline, a systematic search identified 2082 published articles until March 2023. After removing duplicates (189), 1862 citations were screened, resulting in 22 eligible studies with 3332 patients for analysis. The mitral valve prostheses in these studies ranged from 21 to 37 mm, with the 29 mm size being most prevalent. Patient numbers varied, with the FIH subgroup including 31 patients and the older subgroup including 163 patients. Average study durations differed: the older subgroup lasted 4.57 years, the FIH subgroup 2.85 years, and the early phase studies spanned 8.05 years on average. CONCLUSION: FIH clinical report is essential to assess the significance of clinical data required for a "de novo" surgical implant. In addition, understanding the performance of the device, and recognizing the difficulties associated with the innovation constitute important lessons. These insights could be beneficial for the development of bioprosthetic heart valves and formulating a protocol for an FIH clinical trial.

VARC-3 defined outcome of valve-in-valve transcatheter aortic valve implantation in stentless compared with stented aortic bioprostheses.

BACKGROUND: Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is a viable alternative to redo surgery in selected patients with bioprosthetic valve dysfunction. Most ViV-TAVI procedures have been performed in stented bioprosthetic valves (ST); stentless bioprostheses (SL) lack fluoroscopic markers and could be more challenging for ViV-TAVI. Data on more recent patients applying Valve Academic Research Consortium (VARC)-3 defined outcomes are scarce. We compared patient characteristics, procedural outcomes, and 5-year mortality of patients with SL versus ST aortic bioprosthetic valve failure undergoing ViV-TAVI. METHODS: Patients undergoing ViV-TAVI between 2007 and 2022 (52.5% of cases after 2015) at 3 German centers were included in this analysis. The co-primary outcome measures were technical success, device success, and early safety defined by VARC-3. Mortality was assessed up to 5 years. RESULTS: Overall, 43 (11.8%) SL and 313 (88.2%) ST ViV-TAVI were included. Patients were comparable with regard to age, sex, clinically relevant baseline comorbidities, and surgical risk. Technical success (SL: 83.7% versus ST: 79.9%, p = 0.552), device success (SL: 67.4% versus ST: 54.3%, p = 0.105), and early safety (SL: 74.4% versus ST: 66.5%, p = 0.296) were comparable between groups. The 30-day mortality (SL: 7.0% versus ST: 2.6%, p = 0.136) and 5-year mortality rates (SL: 23.3% versus ST: 24.6%, p = 0.874) were not significantly different between groups. CONCLUSION: SL and ST ViV-TAVI led to comparable short-term outcomes according to VARC-3- defined endpoints and similar mortality rates up to 5 years of follow-up. VARC-3 defined technical success, device success, and early safety as well as 5-year all-cause mortality in patients undergoing valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) into stentless (SL) compared with stented (ST) failed aortic bioprostheses.